Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 22813 

Submission.’’ The notice published with 

an inadvertent error in the ADDRESSES

section. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: 

Joyce A. Strong, Office of Policy (HF– 

27), Food and Drug Administration, 

5600 Fishers Lane, Rockville, MD 

20957, 301–827–7010. 

SUPPLEMENTARY INFORMATION: In FR Doc. 

2010–9134, appearing on page 20606, in 

the Federal Register of Tuesday, April 

20, 2010, the following correction is 

made: 

1. On page 20606, in the second 

column, in the ADDRESSES section, the 

second sentence is corrected to read: 

‘‘Send one self-addressed adhesive label 

to assist that office in processing your 

request or include a fax number to 

which the guidance document may be 

sent.’’ 

Dated: April 27, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10160 Filed 4–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0263] 

Guidance for Industry: Requalification 

Method for Reentry of Blood Donors 

Deferred Because of Reactive Test 

Results for Antibody to Hepatitis B 

Core Antigen (Anti-HBc); Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Requalification 

Method for Reentry of Blood Donors 

Deferred Because of Reactive Test 

Results for Antibody to Hepatitis B Core 

Antigen (Anti-HBc),’’ dated May 2010. 

The guidance document provides 

recommendations to establishments that 

collect Whole Blood or blood 

components intended for transfusion, 

with recommendations for a 

requalification method or process for 

reentering deferred donors into the 

donor pool based on a determination 

that previous tests that were repeatedly 

reactive for antibodies to hepatitis B 

core antigen (anti-HBc) were falsely 

positive and that there is no evidence of 

infection with hepatitis B virus (HBV). 

These recommendations are based on 

the recent availability of FDA-licensed 

hepatitis B virus nucleic acid tests (HBV 

NAT) that are particularly sensitive 

when single samples are tested. These 

tests provide an additional, powerful 

method of determining whether a donor 

who has been deferred because of antiHBc reactivity is truly infected by HBV. 

The guidance announced in this notice 

finalizes the draft guidance of the same 

title dated May 2008. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Paul 

E. Levine, Jr., Center for Biologics 

Evaluation and Research (HFM–17), 

Food and Drug Administration, 1401 

Rockville Pike, suite 200N, Rockville, 

MD 20852–1448, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Requalification Method for 

Reentry of Blood Donors Deferred 

Because of Reactive Test Results for 

Antibody to Hepatitis B Core Antigen 

(Anti-HBc),’’ dated May 2010. The 

guidance document provides 

recommendations to establishments that 

collect Whole Blood or blood 

components for a requalification 

method or process for the reentry of 

deferred donors into the donor pool 

based on a determination that previous 

tests that were repeatedly reactive for 

anti-HBc were falsely positive and that 

there is no evidence of infection with 

HBV. Currently, donors who are 

repeatedly reactive on more than one 

occasion for anti-HBc (samples from 

more than one collection from the donor 

are repeatedly reactive for anti-HBc) 

must be indefinitely deferred in 

accordance with current regulations. 

Situations have occurred with some 

frequency in which two anti-HBc tests 

are false positives because of the relative 

non-specificity of these tests. The result 

is that many otherwise suitable donors 

are indefinitely deferred because of their 

anti-HBc test results even though 

medical follow-up of such donors 

indicates that they are not infected with 

HBV. FDA-licensed HBV NAT assays, 

which are particularly sensitive when 

single samples are tested, are now 

available and provide an additional, 

powerful method of determining 

whether a donor who has been deferred 

because of anti-HBc reactivity is truly 

infected by HBV. Due to the availability 

of FDA-licensed HBV NAT assays and 

the improved specificity of anti-HBc 

assays, FDA is recommending in the 

guidance a reentry algorithm for donors 

deferred due to falsely positive 

repeatedly reactive tests for anti-HBc. 

In the Federal Register of May 21, 

2008 (73 FR 29519), FDA announced the 

availability of the draft guidance of the 

same title. FDA received several 

comments on the draft guidance and 

those comments were considered as the 

guidance was finalized. In addition, 

editorial changes were made to improve 

clarity. The guidance announced in this 

notice finalizes the draft guidance dated 

May 2008. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR 601.12 have been approved 

under OMB control number 0910–0338. 

III. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 

that individuals may submit one paper 

copy. Comments are to be identified 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
22814 Federal Register / Vol. 75, No. 83 / Friday, April 30, 2010 / Notices 

with the docket number found in 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination in the Division of 

Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either: 

http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm, http://www.fda.gov/cber/ 

guidelines.htm or http:// 

www.regulations.gov. 

Dated: April 16, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10046 Filed 4–29–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–D–0140] (formerly 

Docket No. FDA–2005D–0261) 

Guidance for Industry: Nucleic Acid 

Testing (NAT) for Human 

Immunodeficiency Virus Type 1 (HIV– 

1) and Hepatitis C Virus (HCV): 

Testing, Product Disposition, and 

Donor Deferral and Reentry; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Guidance for Industry: Nucleic Acid 

Testing (NAT) for Human 

Immunodeficiency Virus Type 1 (HIV– 

1) and Hepatitis C Virus (HCV): Testing, 

Product Disposition, and Donor Deferral 

and Reentry’’ dated May 2010. The 

guidance document provides 

recommendations to blood and plasma 

establishments, manufacturers, and 

testing laboratories that are 

implementing a licensed method for 

Human Immunodeficiency Virus Type 1 

(HIV–1) Nucleic Acid Test (NAT) and 

Hepatitis C Virus (HCV) NAT, on testing 

individual samples or pooled samples 

from donors of human blood and blood 

components for HIV–1 ribonucleic acid 

(RNA) and HCV RNA. This guidance 

also contains recommendations 

regarding product disposition and donor 

management based on the results of 

NAT and serologic testing for markers of 

HIV–1 and HCV infection on samples, 

collected at the time of donation, from 

donors of human blood and blood 

components. The guidance announced 

in this notice finalizes the draft 

guidance of the same title, dated July 

2005. This guidance also supersedes the 

recommendations for reentry of donors 

deferred because of anti-HIV–1 test 

results, HIV–1 p24 antigen test results, 

and anti-HCV test results that were 

provided in the FDA memoranda 

entitled ‘‘Revised Recommendations for 

the Prevention of Human 

Immunodeficiency Virus (HIV–1) 

Transmission by Blood and Blood 

Products,’’ April 23, 1992; ‘‘Revised 

Recommendations for Testing Whole 

Blood, Blood Components, Source 

Plasma and Source Leukocytes for 

Antibody to Hepatitis C Virus Encoded 

Antigen (Anti-HCV),’’ August 5, 1993; 

‘‘Recommendations for Donor Screening 

with a Licensed Test for HIV–1 

Antigen,’’ August 8, 1995. 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, suite 200N, 

Rockville, MD 20852–1448. Send one 

self-addressed adhesive label to assist 

the office in processing your requests. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

Submit electronic or written 

comments on the guidance. Submit 

electronic comments to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: Paul 

Levine, Center for Biologics Evaluation 

and Research (HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Guidance for 

Industry: Nucleic Acid Testing (NAT) 

for Human Immunodeficiency Virus 

Type 1 (HIV–1) and Hepatitis C Virus 

(HCV): Testing, Product Disposition, 

and Donor Deferral and Reentry,’’ dated 

May 2010. The guidance document 

provides recommendations to blood and 

plasma establishments, manufacturers, 

and testing laboratories that are 

implementing a licensed method for 

Human Immunodeficiency Virus Type 1 

(HIV–1) Nucleic Acid Test (NAT) and 

Hepatitis C Virus (HCV) NAT, on testing 

individual samples or pooled samples 

from donors of human blood and blood 

components for HIV–1 ribonucleic acid 

(RNA) and HCV RNA. This guidance 

also contains recommendations 

regarding product disposition and donor 

management based on the results of 

NAT and serologic testing for markers of 

HIV–1 and HCV infection on samples, 

collected at the time of donation, from 

donors of human blood and blood 

components. The guidance announced 

in this notice finalizes the draft 

guidance of the same title, dated July 19, 

2005. This guidance also supersedes the 

recommendations for reentry of donors 

deferred because of anti-HIV–1 test 

results, HIV–1 p24 antigen test results, 

and anti-HCV test results that were 

provided in the FDA memoranda 

entitled, ‘‘Revised Recommendations for 

the Prevention of Human 

Immunodeficiency Virus (HIV–1) 

Transmission by Blood and Blood 

Products,’’ April 23, 1992; ‘‘Revised 

Recommendations for Testing Whole 

Blood, Blood Components, Source 

Plasma and Source Leukocytes for 

Antibody to Hepatitis C Virus Encoded 

Antigen (Anti-HCV),’’ August 5, 1993; 

‘‘Recommendations for Donor Screening 

with a Licensed Test for HIV–1 

Antigen,’’ August 8, 1995. 

In the Federal Register of July 27, 

2005 (70 FR 43439), FDA announced the 

availability of the draft guidance of the 

same title. FDA received several 

comments on the draft guidance and 

those comments were considered as the 

guidance was finalized. The guidance 

announced in this notice finalizes the 

draft guidance dated July 2005. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may, at any time, 

submit to the Division of Dockets 

Management (see ADDRESSES) written or 

electronic comments regarding the 

guidance. Submit a single copy of 

electronic comments or two paper 

copies of any mailed comments, except 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1